Early Patient Access Treatment Use Protocol CA204-220

Not Applicable

• Conditions: relapsed or refractory multiple myeloma

• Registration Number: JPRN-jRCT2080223322
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men and women 20 years and older
Active, relapsed or refractory multiple myeloma by International Myeloma Working Group (IMWG) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy.
Progression from a most recent line of therapy
Prior lenalidomide exposure is permitted only if they fulfill all of the following:
a.Were not refractory to prior lenalidomide, defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrollment.
b.Patient did not discontinue lenalidomide due to a Grade over 3 related AE.

Exclusion Criteria

All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade under 2
Significant cardiac disease as determined by the treating physician including cardiac amyloidosis
Known HIV infection or active hepatitis A, B, or C
Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified